The Safety and Effect Study of Acupuncture for Anorexia in Patients With Gastrointestinal Tract and Lung Cancers

Phase 2

• Conditions: Anorexia; Cancer Cachexia
• Interventions: Other: Acupuncture; Other: Sham Acupuncture; Drug: Placebo(Megestrol Acetate); Drug: Megestrol Acetate

• Registration Number: NCT02619266
• Lead Sponsor: Xinqiao Hospital of Chongqing

Brief Summary

This trail will be carried out to evaluated the effect and safety of acupuncture for the anorexia in patients with gastrointestinal tract and lung cancers.

Detailed Description

Acupuncture used for anorexia related to cancer, but there were lack of powerful evidence. The 160 eligibilities will be randomly divided into 3 groups(Acupuncture and Placebo group, Megestrol acetate and Sham Acupuncture group, Placebo and Sham Acupuncture group).The effect will be investigated baseline, the 2,5,8 and 15days. The safety issue will be recorded every section during the acupuncture.

Study Timeline

• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2015-11-27
• Status Verified: 2015-12
• Study Start: 2015-12
• Study First Posted: 2015-12-02
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-04
• Primary Completion: 2016-12
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Diagnosed gastrointestinal tand lung cancers;
2. Age ≥18 years;
3. Appetite score≤ 6 (0= worst appetite), and the symptom lasted 2 weeks at lest at screening;
4. Had a history of weight loss ≥5% within 6 moths;
5. Maintained oral intake;
6. Signed the informed consent.

Exclusion Criteria

1. Patients with dementia, delirium, intestinal obstruction, pregnancy or lactation;
2. Had uncontrolled symptoms that could impact appetite or caloric intake such as nausea, pain, or depression(The score of the symptoms≤ 3, 0= worst) ;
3. Patients with untreated vitamin B12 deficiency or endocrine abnormalities(thyroid dysfunction and hypoadrenalism);
4. Patients on melatonin supplements or medications with potential appetite-stimulating activity(Chinese herb,thalidomide)
5. Less than one week before the screening or there will be a surgery ,radiotherapy and chemotherapy the acupuncture;
6. Lifetime expected less than 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture+Placebo	Acupuncture	Acupuncture once daily for 7 days and Placebo tablet by mouth, twice a day for 7 days.
Acupuncture+Placebo	Placebo(Megestrol Acetate)	Acupuncture once daily for 7 days and Placebo tablet by mouth, twice a day for 7 days.
Megestrol Acetate+Sham acupuncture	Sham Acupuncture	Megestrol Acetate tablet 160mg by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days .
Megestrol Acetate+Sham acupuncture	Megestrol Acetate	Megestrol Acetate tablet 160mg by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days .
Placebo+Sham acupuncture	Sham Acupuncture	Placebo tablet by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days .
Placebo+Sham acupuncture	Placebo(Megestrol Acetate)	Placebo tablet by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days .

Primary Outcome Measures

Name	Time	Method
Appetite Visual Analog Scale	Baseline, the days 8 and 15.	The assessment will be done thirty minutes before meals. The participators should record the score of their appetite (0 to 100 mm) the higher scores reflect better symptom control.

Secondary Outcome Measures

Name	Time	Method
Council of Nutrition appetite questionnaire (CNAQ)	Baseline, the days 8 and 15.	Ask the subjects to complete the questionnaire by circling the correct answers and then tally the results based upon the following numerical scale: a =1, b = 2, c = 3, d = 4, e = 5. The sum of the scores for the individual items constitutes the CNAQ score. CNAQ score ≤28 indicates significant risk of at least 5% weight loss within six months.
Caloric intake	Baseline, the days 8 and 15.	The caloric intake will be assessed by the dietician.
Functional Assessment of Anorexia/Cachexia Therapy	Baseline, the days 8 and 15.	Functional Assessment of Anorexia/Cachexia Therapy was designed to measure general aspects of quality of life (QOL) as well as specific anorexia/cachexia-related concerns.
Nutritional status	Baseline, the days 8 and 15.	weight was determined in kilograms. Triceps skinfold (mm), arm circumference(cm), and calf circumference (cm) were determined

Trial Locations

Locations (4)

Chongqing TCM Hospital; 🇨🇳 Jiangbei, Chongqing, China

XinQiao Hosiptal; 🇨🇳 Shapingba, Chongqing, China

Donghua Hosiptal; 🇨🇳 Shapingba, Chongqing, China

Daping Hospital; 🇨🇳 Yuzhong, Chongqing, China